Ultrasonic Transducer Probe Cover Recalled for Lacking FDA Clearance
Exact Medical Manufacturing recalled 5,621 ultrasonic transducer probe covers (Item A-AU-1002N) lacking FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The issue is regulatory—the product lacks required FDA 510(k) clearance for certain uses—rather than a documented safety defect. Per the severity rubric, Class II recalls without reported harm warrant a Moderate rating.
Plain-English summary
Exact Medical Manufacturing is recalling 5,621 ultrasonic transducer probe covers (Lite poly, 6"x48" with two bands, Item ID A-AU-1002N) because the product lacks FDA 510(k) pre-market clearance for use in natural or surgical body openings.
The product was distributed to healthcare facilities in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico. The affected lot numbers are 1907E241, 1909E199, 1908E437, 1912E125, 2003E828, 2005E443, and 2005E175.
Users should discontinue use of the affected product for applications requiring FDA clearance and contact Exact Medical Manufacturing for guidance on replacement or appropriate use.
The recalled product
- Product
- Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- Affected units
- 5,621
Distribution
Part of a larger recall action
This product is one of 18 recalled by Exact Medical Manufacturing, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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